Predictors and Prognostic Factors on the Acute Ischemic Stroke

A Prospective Cohort Study of Predictors and Prognostic Factors on the Acute Ischemic Stroke

Through 5 years continuous observation of acute ischemic stroke patients in Neurology Department of Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, clinical data about emergency treatment (neurological score, examination and treatment), medical data after admission (neurological score, inspection, examination and treatment) and long-term prognosis (neurological score) was collected. The outcomes were set as the score scale, all blood test index and examination index of the research objects at specific period after illness. Through statistical analysis and comparison of different in-hospital clinical data in predicting the outcome of the patients, our study will provide more evidence-based solutions for the treatment and prediction of acute ischemic stroke.

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: Drug Therapy; Diagnostic test: Routine Blood Test and Image Scan; Other: Intravascular therapy; Other: Emergency Treatment; Other: Medical history

Detailed Description

The research is designed as registrated, prospective, open-labeled, blind-endpoint, and the research objects are continuously recorded. The final subgroups are blind to neurological evaluators, data inputers and statisticians.

The research is a continuous observational exploratory study. All patients with ischemic stroke admitted to Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology from April 1, 2017 to December 31, 2021 will be included. According to the current situation, it is expected to enroll approximately 5000 of eligible patients for long-term follow-up observation.

We'll use multiple linear regression analysis model to study factors and confounding factors and their interaction. And we will control the confounding factors, and make a quantitative description of the relationship between factors and outcome variables.

Missing cases will be treated as censored values, and the ratio of missing cases will be recorded. All samples will be analyzed by Intent-to-Treat (ITT) analysis. In the analysis, if the results are statistically significant, the missing cases in the exposed group will be deleted, and the missing cases in non-exposure group be added. If the results are still statistically significant, then the missing cases are defined as not affecting the analysis results.

If the heterogeneity of data is large, the objects will be analyzed in subgroups according to age or sex.

If the missing rate is greater than 20%, it is necessary to analyze the sensitivity of the whole sample.

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients with ischemic stroke admitted to Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology from April 1, 2017 to December 31, 2021 will be included.

Description

Inclusion Criteria:

• ≥18 years old, of either sex
• Confirmation by CT scan
• Willingness to participate in the study and comply with its procedures by signing a written informed consent

Exclusion Criteria:

• Cerebral hemorrhagic infarction confirmed by CT scan
• Patients with severe systemic disease who are expected to survive for no more than three months
• Unwilling to participate in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients With Ischemic Stroke; The patients with all types of ischemic stroke including TIA, small vessle diseases, MCAO, and ect. These patients will be recorded their emergency treatment, medical history, details about their drug therapy, results of their routine blood test and image scan, and whether they receive intravascular therapy in time or not.	Drug: Drug Therapy; For this observation research, anti platelet drugs, statins and ect. would be used as clinical guidelines as usal, and statical ananysis of the relationship between these drugs and the final outcomes; Other Names: Aspirin; Clopidogrel; Statin; Diagnostic test: Routine Blood Test and Image Scan; Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.); Other: Intravascular therapy; Intravascular therapy including thrombectomy; Other: Emergency Treatment; Emergency treatment including time to self-diagnosis of stroke, time to call for help, devices used to hospital and ect.; Other: Medical history; Medical history including hypertension, diabetes, hyperlipemia and ect.
Healthy Control; The patients admitted to hospital for symptoms like dizzness and headache, which later proved to be not related to cerebral vascular diseases, would be treated as control. Their medical history and the results of their routine blood test and image scan will be recorded.	Diagnostic test: Routine Blood Test and Image Scan; Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.); Other: Medical history; Medical history including hypertension, diabetes, hyperlipemia and ect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale scores	0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead.	Change from Baseline mRS score at 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-admission to the hospital	Re-admission to the hospital (patients without new symptoms and admitted to the hospital simply for physical examination are not counted)	24 months
Cerebral and Cardio vascular diseases	Cerebral and Cardio vascular diseases including small vessel diseases, white matter ischemia, micro hemorrhage, ischemic stroke and hemorrhagic stroke.	24 months
Neurological deterioration-1	Neurological deterioration (NIHSS score)	Change from Baseline NIHSS score at 24 months
Neurological deterioration-2	Neurological deterioration (FAQ score)	Change from Baseline FAQ score at 24 months
Cognitive dysfunction	Cognitive dysfunction (MMSE score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5	Change from Baseline MMSE score at 24 months
Cognitive dysfunction	Cognitive dysfunction (MoCA score). Patients with cognitive dysfunction will be classified into mild neurocognitive disorder, major neurocognitive disorder according to DSM-5	Change from Baseline MoCA score at 24 months
Cerebrospinal Fluid (CSF) test	Cerebrospinal Fluid (CSF) test including Tau, Aβ and ect.	24 months
Blood test	Blood including HCY, amino acid, LDL and ect.	24 months
Depression	Hamilton Depression Scale	24 months
Severe pulmonary infection	Severe pulmonary infection	24 months

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Wei Wang, PhD, MD, Tongji Hospital

Publications and helpful links

General Publications

• Shang K, Chen X, Cheng C, Luo X, Xu S, Wang W, Liu C. Arterial Tortuosity and Its Correlation with White Matter Hyperintensities in Acute Ischemic Stroke. Neural Plast. 2022 Mar 24;2022:4280410. doi: 10.1155/2022/4280410. eCollection 2022.
• Qin C, Zhao XL, Ma XT, Zhou LQ, Wu LJ, Shang K, Wang W, Tian DS. Proteomic profiling of plasma biomarkers in acute ischemic stroke due to large vessel occlusion. J Transl Med. 2019 Jul 1;17(1):214. doi: 10.1186/s12967-019-1962-8.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 16, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 3, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Cerebral Infarction; Cerebrovascular Disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: Know more about AIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No